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Real-World Data from Turkey: Is Sofosbuvir/Ledipasvir With or Without Ribavirin Treatment for Chronic Hepatitis C Really Effective?

Neşe Demirtürk 1 , Bilgehan Aygen 2 , İlhami Çelik 3 , Reşit Mıstık 4 , Sıla Akhan 5 , Şener Barut 6 , Onur Ural 7 , Ayşe Batırel 8 , Funda Şimşek 9 , Gülden Ersöz 10 , Dilara İnan 11 , Sami Kınıklı 12 , Nesrin Türker 13 , Hüseyin Bilgin 14 , Yunus Gürbüz 15 , Necla Tülek 16 , Hüseyin Tarakçı 17 , Orhan Yıldız 2 , Emine Türkoğlu 1 , Deniz Kamalak Güzel 3 , Sümeyra Şimşek 18 , Nazan Tuna 19 , Nazlım Aktuğ Demir 7 , Atahan Çağatay 20 , Rıza Aytaç Çetinkaya 21 , Faruk Karakeçili 22 , İsmail Necati Hakyemez 23 , Günay Tuncer Ertem 12 , Bahar Örmen 13 , Pınar Korkmaz 24 , Uluhan Yıldız 14 , Ziya Kuruüzüm 25 , Alper Şener 26 , Selcan Arslan Özel 27 , Sinan Öztürk 28 , Kaya Suer 29 , Mustafa Kemal Çelen 30 , Petek Konya 1 , Ali Asan 31 , Neşe Saltoğlu 32 , Nurhan Doğan 33
1.

Department of Infectious Disease and Clinical Microbiology, Afyon Saglik Bilimleri University Medical Faculty, Afyonkarahisar, Turkey

2.

Department of Infectious Disease and Clinical Microbiology, Erciyes University Medical Faculty, Kayseri, Turkey

3.

Department of Infectious Diseases and Clinical Microbiology, Kayseri Education and Research Hospital, Saglik Bilimleri University, Kayseri, Turkey

4.

Infectious Disease Clinic, Medicana Hospital, Bursa, Turkey

5.

Department of Infectious Disease and Clinical Microbiology, Kocaeli University Medical Faculty, Kocaeli, Turkey

6.

Department of Infectious Disease and Clinical Microbiology, Gaziosmanpasa University Medical Faculty, Tokat, Turkey

7.

Department of Infectious Disease and Clinical Microbiology, Selcuk University Medical Faculty, Konya, Turkey

8.

Department of Infectious Diseases and Clinical Microbiology, Kartal Lütfi Kırdar Education and Research Hospital, Saglik Bilimleri University, İstanbul, Turkey

9.

Department of Infectious Diseases and Clinical Microbiology, Ok Meydanı Education and Research Hospital, Saglik Bilimleri University, İstanbul, Turkey

10.

Department of Infectious Disease and Clinical Microbiology, Mersin University Medical Faculty, Mersin, Turkey

11.

Department of Infectious Disease and Clinical Microbiology, Akdeniz University Medical Faculty, Antalya, Turkey

12.

Department of Infectious Diseases and Clinical Microbiology, Ankara Education and Research Hospital, Saglik Bilimleri University, Ankara, Turkey

13.

Department of Infectious Disease and Clinical Microbiology, Atatürk Education and Research Hospital, Katip Çelebi University, İzmir, Turkey

14.

Department of Infectious Disease and Clinical Microbiology, Marmara University Medical Faculty, İstanbul, Turkey

15.

Department of Infectious Disease and Clinical Microbiology, Dışkapı Education and Research Hospital University Medical Faculty, Saglik Bilimleri University, Antalya, Turkey

16.

Department of Infectious Disease and Clinical Microbiology, Atılım University Medical Faculty, Ankara, Turkey

17.

Department of Infectious Diseases and Clinical Microbiology, Eşrefpaşa Education and Research Hospital, Saglik Bilimleri University, İzmir, Turkey

18.

Department of Infectious Disease and Clinical Microbiology, Uludağ University Medical Faculty, Bursa, Turkey

19.

Department of Infectious Diseases and Clinical Microbiology, Sakarya Education and Research Hospital, Saglik Bilimleri University, Sakarya, Turkey

20.

Department of Infectious Disease and Clinical Microbiology, İstanbul University İstanbul Medical Faculty, İstanbul, Turkey

21.

Department of Infectious Diseases and Clinical Microbiology, Sultan Abdülhamid Han Education and Research Hospital, Saglik Bilimleri University, İstanbul, Turkey

22.

Department of Infectious Diseases and Clinical Microbiology, Erzincan University of Faculty of Medicine, Erzincan, Turkey

23.

Department of Infectious Diseases and Clinical Microbiology, Bezmiâlem University of Faculty of Medicine, İstanbul, Turkey

24.

Department of Infectious Diseases and Clinical Microbiology, Kütahya Health Sciences University Faculty of Medicine, Kütahya, Turkey

25.

Department of Infectious Disease and Clinical Microbiology, Dokuz Eylül University Faculty, İzmir, Turkey

26.

Department of Infectious Diseases and Clinical Microbiology, Çanakkale Onsekiz Mart University Faculty of Medicine, Çanakkale, Turkey

27.

Department of Infectious Diseases and Clinical Microbiology, Kocaeli Training and Research Hospital, Saglik Bilimleri University, Kocaeli, Turkey

28.

Department of Infectious Diseases and Clinical Microbiology, Ümraniye Education and Research Hospital, Saglik Bilimleri University, Kocaeli, Turkey

29.

Department of Infectious Diseases and Clinical Microbiology, Yakın Doğu University of Faculty of Medicine, Nicosia, Turkey

30.

Department of Infectious Diseases and Clinical Microbiology, Dicle University Faculty of Medicine, Diyarbakır, Turkey

31.

Department of Infectious Diseases and Clinical Microbiology, Bursa Yüksek İhtisas Training and Research Hospital, Saglik Bilimleri University, Bursa, Turkey

32.

Department of Infectious Diseases and Clinical Microbiology, İstanbul University of Cerrahpaşa Faculty of Medicine, İstanbul, Turkey

33.

Department of Biostatistics and Medical Informatics, Afyon Saglik Bilimleri University Medical Faculty, Afyonkarahisar, Turkey

Turk J Gastroenterol 2021; 32: 155-163
DOI: 10.5152/tjg.2020.19569
Keywords : Chronic hepatitis C, sofosbuvir, ledipasvir, sustained virological response, genotype, real-world data
Read: 1316 Downloads: 654 Published: 01 February 2021
Volume 32, Issue 2, February 2021
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Background: In this study, we aimed to investigate the efficacy and safety of sofosbuvir-based therapies in the treatment of chronic hepatitis C in real-world clinical practice.

Methods: Data from patients with chronic hepatitis C treated with SOF/LDV ± RBV or SOF/RBV in 31 centers across Turkey between April 1, 2017, and August 31, 2018, were recorded in a nationwide database among infectious disease specialists. Demographics, clinical, and virological outcomes were analyzed.

Results: A total of 552 patients were included in the study. The mean age of the patients was 51.28 ± 14.2, and 293 (55.8%) were female. The majority had HCV genotype 1b infection (65%), 75.04% of the patients underwent treatment, and non-cirrhosis was present at baseline in 381 patients (72.6%). SOF/LDV ± RBV treatment was given to 477 patients and 48 patients received SOF/RBV according to HCV genotype. The total SVR12 rate was 99% in all patients. Five patients experienced disease relapse during the study and all of them were genotype 2. In patients infected with HCV GT2, SVR12 was 77.3%. SVR was 100% in all patients infected with other HCV genotypes. All treatments were well tolerated by patients without causing severe adverse events. Side effects and side effects-associated treatment discontinuation rates were 28.2% and 0.4%, respectively. Weakness (13.7%) was the common side effect.

Conclusion: The present real-world data of 525 patients with HCV genotypes 1, 1a, 1b, 3, 4, and 5 who underwent SOF/LDV ± RBV treatment in Turkey demonstrated a high efficacy and safety profile. HCV GT2 patients should be treated with more efficacious treatment.

Cite this article as: Demirtürk N, Aygen B, Çelik İ, et al. Real-world data from turkey: Is sofosbuvir/ledipasvir with or without ribavirin treatment for chronic hepatitis C really effective?. Turk J Gastroenterol. 2021; 32(2): 155-163.322

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